Codman Neuro, a division of Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes, said the FDA labeled its Trufill n-BCA liquid embolic system recall as Class I, the federal watchdog agency’s highest-risk classification.
The Raynham, Mass.-based company develops devices for neurosurgery, neurovascular repair and neuromodulation. The Trufill is designed to treat abnormal connections between the arteries and veins in the brain. The recall was initiated in October 2013 due to an error in the instructions for use, which gave the wrong mixing ratio.
The product is not being removed from the market, as the company is going to inform doctors of the issue and make the update. No patients have been reported dead or permanently injured corresponding to the recall, according to a prepared statement.
The affected lots were under the 631400 and 631500 product code and were manufactured from February 25, 2010, to October, 31, 2013. Codman Neuro is encouraging physicians to call and report any malfunctions, in addition to noting the correction notice for the improved mixing instructions.